Drug discontinuations in the United Kingdom and the United States, 1964 to 1983: Issues of safety

  title={Drug discontinuations in the United Kingdom and the United States, 1964 to 1983: Issues of safety},
  author={Olav M. Bakke and William M. Wardell and Louis Lasagna},
  journal={Clinical Pharmacology \& Therapeutics},
Since the modern era of drug regulation began in the early 1960s, fewer new drugs have been approved for marketing in the United States than in the United Kingdom. We examined whether information can be obtained about the relative safety of higher and lower introductory rate policies by comparing each country's record of drugs that have been discontinued (removed from the market, withdrawn, or whose licenses were allowed to lapse) while a question of safety existed. We have compiled a list of… 
Drug safety discontinuations in the United Kingdom, the United States, and Spain from 1974 through 1993: A regulatory perspective
The therapeutic classes most commonly associated with safety discontinuations were the nonsteroidal anti‐inflammatory drugs, vasodilators, and antidepressants, and U.S. companies or their foreign subsidiaries were involved as originators (patent‐holders and/or developers) of approximately 40% of the drugs discontinued for safety reasons.
The drug lag: An update of new drug introductions in the United States and in the United Kingdom, 1977 through 1987
The results indicate that the United States continues to lag behind the United Kingdom in the availability of new drugs.
A Drug Lag Update
IN THE MID-l970s, Wardell’s pioneering drug lag studies revealed a therapeutically significant delay in the introduction of new drugs in the United States compared with the United Kingdom ( 1,2).
Evaluation of the Characteristics of Safety Withdrawal of Prescription Drugs from Worldwide Pharmaceutical Markets-1960 to 1999*
A descriptive analysis was conducted to evaluate prescription drugs withdrawn from worldwide pharmaceutical markets over the past four decades due to safety reasons, finding that the most common categories of drugs withdrawn were: Non-Steroidal Anti-Inflammatory Drugs, nonnarcotic analgesics, antidepressants, and vasodilators.
New active substances authorized in the United Kingdom between 1972 and 1994.
There is marked heterogeneity in the annual rates of authorisation of new active substances, and the provisional nature of assessments about safety at the time when a new active substance is introduced into routine clinical practice is confirmed, confirming the importance of pharmacovigilance.
A comparative analysis of drug safety withdrawals in the UK and the US (1971-1992): implications for current regulatory thinking and policy.
It is concluded that the main explanation for fewer drug safety withdrawals in the US is that the regulatory agency there applied more stringent pre-market review and/or standards, which took longer than UK regulatory checks, but prevented unsafe drugs marketed in the UK from entering the US market.
Privacy and medical research
21 had been marketed in the United Kingdom, 14 had been marketed in the United States of America, while only II had been marketed in Australia.' Of the II drugs, six had been introduced before the
Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature
There are discrepancies in the patterns of withdrawal of medicinal products from the market when adverse reactions are suspected, and withdrawals are inconsistent across countries.
Timing of new black box warnings and withdrawals for prescription medications.
To determine the frequency and timing of discovery of new ADRs described in black box warnings or necessitating withdrawal of the drug from the market, Examination of the Physicians' Desk Reference for all new chemical entities approved by the US Food and Drug Administration between 1975 and 1999 is examined.
Drug regulation in the United States and the United Kingdom: the Depo-Provera story.
It is concluded that differing national policies helped shape the interpretation of the data and thus the divergent outcomes of Depo-Provera as a long-term contraceptive agent.


The drug lag revisited: Comparison by therapeutic area of patterns of drugs marketed in the United States and Great Britain from 1972 through 1976
  • W. Wardell
  • Medicine
    Clinical pharmacology and therapeutics
  • 1978
The largest differences have narrowed since the previous study, but important categories in which the U.S. still lagged behind Britain in December, 1976, included cardiovascular drugs, peptic ulcer drugs, and central nervous system drugs, including therapies for depression, epilepsy, and migraine.
Research activity on systemic contraceptive drugs by the U.S. pharmaceutical industry, 1963-1976.
This study shows declining activity in research on contraceptive NCEs by the U.S. industry, thus supporting to some extent Djerassi's prediction of a decade ago, and it should be recognized that it does not include complete data on the research activities in this area by the United States government or other non-industrial organizations, or on research sponsored by any group on new contraceptive methods other than N CEs.
Licensing times in granting marketing authorization for medicinesa comparison
  • 1982
Licensing times in granting marketing authorization for medicinesa comparison between the
  • Pharm Int
  • 1982
Licensing times in granting marketing authorization for medicinesa comparison between the U . K . and U . S . A
  • Pharm Int
  • 1982
editor: Martindale, the extra pharmacopoeia, ed 28
  • 1982
A survey of products licensed in the United Kingdom from 1971-1981.
Identification of adverse reactions to new drugs . I : What have been the important Drug discontinuations in the U . K . and the U . S . 567 adverse reactions since thalidomide ?
  • Br Med J
  • 1975